Poor Sleep QualityNCT06430086
Mechanistic Effect of Walnut Consumption on Sleep Quality
A study testing Walnut consumption and HCHS consumption in people with Poor Sleep Quality, run by Columbia University at 1 site in United States.
Trial summary
Poor sleep quality is very common in modern society. Walnuts contain many nutrients that may be helpful for sleep, including melatonin and polyphenols. Some studies show that eating foods high in melatonin and polyphenols improves sleep quality, but walnuts have not been studied specifically. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Sleep Quality
- What is being tested?
- Walnut consumption and HCHS consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Equal numbers of men and women (12 male and 12 post-menopausal female)
- Equal number of individuals with normal weight (18.5-24.9 kg/m2) and overweight (25-29.9 kg/m2)
- Participants will self-report poor sleep quality, reflected by a global score >5 on Pittsburgh Sleep Quality Index
Who cannot join
- Diagnosed sleep disorder
- Participants with conditions that could affect sleep will be excluded:
- smoking, excessive caffeine intake (>300 mg/day)
- shift work
- chronic pain
- diagnosis of a chronic disease (e.g., uncontrolled hypertension, pre-diabetes, type 2 diabetes, chronic kidney disease, chronic obstructive pulmonary disease),
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- autoimmune diseases
- cardiovascular event or cancer in the past 24 months
- psychiatric/neurologic disease or disorder, or sleep disorder (diagnosed or high risk for sleep apnea, chronic insomnia, restless leg syndrome, narcolepsy)
- use of medications that influence CYP1A2 enzymes
- Allergy/intolerance to nuts, tree nuts, or unwilling to eat study foods
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Joseariel Romero, 347-963-8845, jr4119@cumc.columbia.edu
Marie-Pierre St-Onge, PhD
About this study
Poor sleep quality is very common in modern society. Walnuts contain many nutrients that may be helpful for sleep, including melatonin and polyphenols. Some studies show that eating foods high in melatonin and polyphenols improves sleep quality, but walnuts have not been studied specifically. This study proposes to test if eating walnuts improves sleep compared to a food that lacks these sleep-promoting factors. The investigators expect that walnut consumption for 4 days will increase melatonin levels and lead to better sleep quality compared to a high-carbohydrate, high-sugar food. The study will enroll middle-aged and older adults with sleep complaints to participate in this study. Each person will eat the two different foods for 4 days each in random order. The 4-day periods will be separated by at least 2-3 weeks. Sleep quality will be measured by questionnaire and with a wrist monitor every day. The investigators will also do a sleep study using electroencephalography (EEG) on night 3 and take measures of circadian physiology (natural body rhythms) in the laboratory on day 4 (including overnight) by measuring body temperature and blood and urine melatonin. The study findings may provide new options to improve sleep health from increased walnut consumption.
Read the detailed description
Walnuts are a nutrient-rich food which provides melatonin and polyphenols. While there is evidence that dietary intakes of foods high in melatonin and polyphenols positively influence sleep quality, the effect of walnuts has not been investigated. The investigators propose to fill this knowledge gap by testing the effects of walnut consumption on serum melatonin and resulting sleep and circadian biology. The study hypotheses are that walnut consumption for 4 days will increase melatonin levels, suggestive of more robust circadian rhythms, and lead to better sleep quality compared to a high-carbohydrate high-sugar (HCHS) equivalent. Using a randomized controlled crossover trial, the study aims to: 1) determine the effect of walnut vs HCHS consumption on melatonin levels; and 2) determine the effect of walnut vs HCHS consumption on sleep and circadian physiology. Adult males and females with poor sleep quality will consume three servings/day of walnuts or an equicaloric HCHS food for 4 days. Sleep quality will be measured nightly using the Karolinska Sleep Diary and wrist actigraphy; sleep architecture from polysomnography will be measured on night 3. Circadian physiology will be assessed on day 4 using body temperature and hourly serum melatonin and on the morning of day 5 from overnight urinary 6-sulfatoxymelatonin. Given the extent of poor sleep, our findings may open new avenues to improve sleep health from increased walnut consumption.
- Conditions
- Poor Sleep Quality
- Being tested
- Walnut consumption, HCHS consumption
- Keywords
- Randomized crossover study, Controlled feeding, Dietary intervention, Inpatient visit, Outpatient monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walnut consumptionOther
Participants will add one serving (1 oz) of walnuts at their self-defined breakfast, lunch, and dinner for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day.
HCHS consumptionOther
Participants will add one HCHS food (one PopTarts® pastry) to each of their 3 main meals of the day for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day.
An energy-matched high-carbohydrate, high-sugar (HCHS) alternative, representative of a common US snack food, on sleep quality in adults with habitually poor sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Walnut - washout - HCHS | Experimental | Participants will consume 3 servings/day of walnuts (3 oz/d) over 4 days and have a washout for 2-3 weeks then crossover to consume 3 equicaloric servings of a HCHS food over 4 days.
Over each 4-day period, participants will sleep and eat at home for the first 3 days and will be admitted to the Inpatient Clinical Research Resource of the Irving Institute for Clinical and Translational Research of CUIMC on day 4 for in-depth profiling circadian physiology. Participants will be discharged on the morning of day 5. Receives: Other: Walnut consumption; Other: HCHS consumption |
| HCHS - washout - Walnut | Experimental | Participants will consume 3 equicaloric servings of a HCHS food over 4 days and have a washout for 2-3 weeks then crossover to consume 3 servings/day of walnuts (3 oz/d) for 4 days.
Over each 4-day period, participants will sleep and eat at home for the first 3 days and will be admitted to the Inpatient Clinical Research Resource of the Irving Institute for Clinical and Translational Research of CUIMC on day 4 for in-depth profiling circadian physiology. Participants will be discharged on the morning of day 5. Receives: Other: Walnut consumption; Other: HCHS consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum melatonin
Serum melatonin will be measured via last testing of blood samples collected on day 4, in an inpatient setting. Repeated for each phase.
Measured: Baseline (9AM; Hour 0), Hour 1, Hour 2, Hour 3, Hour 4, Hour 5, Hour 6, Hour 7, Hour 8, Hour 9, Hour 10, Hour 11, Hour 12, Hour 13, Hour 14, Hour 15 (Midnight)
Sleep quality index
Sleep quality will be assessed daily using wrist actigraphy. Variables include sleep fragmentation index and sleep efficiency. Repeated for each phase.
Measured: Night 1, Night 2, Night 3, Night 4
Slow wave sleep index
Slow wave sleep will be measured using electroencephalography, in the participant's home. Repeated for each phase.
Measured: Night 3
Secondary outcomes (3)
6-sulfatoxymelatonin level
This is to measure Melatonin production in urine samples. Repeated for each phase.
Measured: Night 4 to morning of Day 5 (Approximately up to 12 hours)
Body temperature
Proximal to distal body temperature gradient measured using thermochron devices (iButtons). Repeated for each phase. In patient. Over 24 hours.
Measured: Day 4
Sleep quality score
Self-reported sleep quality assessed using the Karolinska Sleep Diary (higher score represents better sleep). Repeated for each phase.
Measured: Days 2, 3, 4, 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start28 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Sleep QualityStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), California Walnut Commission
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, PhD, Principal investigator, Associate Professor of Nutritional Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430086
- Sponsor's protocol ID
- AAAV1362
- Other IDs
- GRANT13949102
- Status last verified
- Jul 2026
- First submitted
- 21 May 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be submitted to Zenodo, a generalist repository that is participating in the NIH Generalist Repository Ecosystem Initiative. We will submit metadata associated with the datasets to Zenodo. The repository will provide metadata, persistent identifiers, and long-term access for open and controlled access. Each study created in Zenodo is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication. To request access of the data, researchers will use the standard processes at Zenodo. Given that we seek the widest possible availability, in most cases all that is necessary is obtaining a Zenodo account from the repository web site.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Effect of Walnut Consumption on Sleep Quality
- ClinicalTrials.gov ID
- NCT06430086
- Acronym / sponsor ID
- AAAV1362
- Conditions
- Poor Sleep Quality
- Keywords
- Randomized crossover study, Controlled feeding, Dietary intervention, Inpatient visit, Outpatient monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), California Walnut Commission
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Poor sleep quality is very common in modern society. Walnuts contain many nutrients that may be helpful for sleep, including melatonin and polyphenols. Some studies show that eating foods high in melatonin and polyphenols improves sleep quality, but walnuts have not been studied specifically. This study proposes to test if eating walnuts improves sleep compared to a food that lacks these sleep-promoting factors. The investigators expect that walnut consumption for 4 days will increase melatonin levels and lead to better sleep quality compared to a high-carbohydrate, high-sugar food. The study will enroll middle-aged and older adults with sleep complaints to participate in this study. Each person will eat the two different foods for 4 days each in random order. The 4-day periods will be separated by at least 2-3 weeks. Sleep quality will be measured by questionnaire and with a wrist monitor every day. The investigators will also do a sleep study using electroencephalography (EEG) on night 3 and take measures of circadian physiology (natural body rhythms) in the laboratory on day 4 (including overnight) by measuring body temperature and blood and urine melatonin. The study findings may provide new options to improve sleep health from increased walnut consumption.
Detailed description
Walnuts are a nutrient-rich food which provides melatonin and polyphenols. While there is evidence that dietary intakes of foods high in melatonin and polyphenols positively influence sleep quality, the effect of walnuts has not been investigated. The investigators propose to fill this knowledge gap by testing the effects of walnut consumption on serum melatonin and resulting sleep and circadian biology. The study hypotheses are that walnut consumption for 4 days will increase melatonin levels, suggestive of more robust circadian rhythms, and lead to better sleep quality compared to a high-carbohydrate high-sugar (HCHS) equivalent. Using a randomized controlled crossover trial, the study aims to: 1) determine the effect of walnut vs HCHS consumption on melatonin levels; and 2) determine the effect of walnut vs HCHS consumption on sleep and circadian physiology. Adult males and females with poor sleep quality will consume three servings/day of walnuts or an equicaloric HCHS food for 4 days. Sleep quality will be measured nightly using the Karolinska Sleep Diary and wrist actigraphy; sleep architecture from polysomnography will be measured on night 3. Circadian physiology will be assessed on day 4 using body temperature and hourly serum melatonin and on the morning of day 5 from overnight urinary 6-sulfatoxymelatonin. Given the extent of poor sleep, our findings may open new avenues to improve sleep health from increased walnut consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Walnut - washout - HCHS | Experimental | Other: Walnut consumption, Other: HCHS consumptionParticipants will consume 3 servings/day of walnuts (3 oz/d) over 4 days and have a washout for 2-3 weeks then crossover to consume 3 equicaloric servings of a HCHS food over 4 days. Over each 4-day period, participants will sleep and eat at home for the first 3 days and will be admitted to the Inpatient Clinical Research Resource of the Irving Institute for Clinical and Translational Research of CUIMC on day 4 for in-depth profiling circadian physiology. Participants will be discharged on the morning of day 5. |
| HCHS - washout - Walnut | Experimental | Other: Walnut consumption, Other: HCHS consumptionParticipants will consume 3 equicaloric servings of a HCHS food over 4 days and have a washout for 2-3 weeks then crossover to consume 3 servings/day of walnuts (3 oz/d) for 4 days. Over each 4-day period, participants will sleep and eat at home for the first 3 days and will be admitted to the Inpatient Clinical Research Resource of the Irving Institute for Clinical and Translational Research of CUIMC on day 4 for in-depth profiling circadian physiology. Participants will be discharged on the morning of day 5. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Equal numbers of men and women (12 male and 12 post-menopausal female)
- Equal number of individuals with normal weight (18.5-24.9 kg/m2) and overweight (25-29.9 kg/m2)
- Participants will self-report poor sleep quality, reflected by a global score >5 on Pittsburgh Sleep Quality Index
Key exclusion criteria (11 listed)
- Diagnosed sleep disorder
- Participants with conditions that could affect sleep will be excluded:
- Allergy/intolerance to nuts, tree nuts, or unwilling to eat study foods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walnut consumptionParticipants will add one serving (1 oz) of walnuts at their self-defined breakfast, lunch, and dinner for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day. | Other | HCHS - washout - Walnut, Walnut - washout - HCHS |
| HCHS consumptionParticipants will add one HCHS food (one PopTarts® pastry) to each of their 3 main meals of the day for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day. An energy-matched high-carbohydrate, high-sugar (HCHS) alternative, representative of a common US snack food, on sleep quality in adults with habitually poor sleep quality. | Other | HCHS - washout - Walnut, Walnut - washout - HCHS |
Primary outcome
Serum melatonin
Time frame: Baseline (9AM; Hour 0), Hour 1, Hour 2, Hour 3, Hour 4, Hour 5, Hour 6, Hour 7, Hour 8, Hour 9, Hour 10, Hour 11, Hour 12, Hour 13, Hour 14, Hour 15 (Midnight)
Serum melatonin will be measured via last testing of blood samples collected on day 4, in an inpatient setting. Repeated for each phase.
Sleep quality index
Time frame: Night 1, Night 2, Night 3, Night 4
Sleep quality will be assessed daily using wrist actigraphy. Variables include sleep fragmentation index and sleep efficiency. Repeated for each phase.
Slow wave sleep index
Time frame: Night 3
Slow wave sleep will be measured using electroencephalography, in the participant's home. Repeated for each phase.
3 secondary outcomes
6-sulfatoxymelatonin level
Time frame: Night 4 to morning of Day 5 (Approximately up to 12 hours)
Body temperature
Time frame: Day 4
Sleep quality score
Time frame: Days 2, 3, 4, 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. Data will be submitted to Zenodo, a generalist repository that is participating in the NIH Generalist Repository Ecosystem Initiative. We will submit metadata associated with the datasets to Zenodo. The repository will provide metadata, persistent identifiers, and long-term access for open and controlled access. Each study created in Zenodo is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication. To request access of the data, researchers will use the standard processes at Zenodo. Given that we seek the widest possible availability, in most cases all that is necessary is obtaining a Zenodo account from the repository web site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Pierre St-Onge, PhD principal investigator
Associate Professor of Nutritional Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walnut consumption and HCHS consumption in people with Poor Sleep Quality, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseariel Romero (347-963-8845, jr4119@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum melatonin (time frame: Baseline (9AM; Hour 0), Hour 1, Hour 2, Hour 3, Hour 4, Hour 5, Hour 6, Hour 7, Hour 8, Hour 9, Hour 10, Hour 11, Hour 12, Hour 13, Hour 14, Hour 15 (Midnight)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.